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Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.

The Achieve Programmable Automatic Biopsy System is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

The Achieve® Programmable Automatic Biopsy Systems are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. The device provides precise control and quality sampling capability when working with calcified or fibrous lesions. The lightweight system offers spring-loaded action for fast, accurate penetration of dense tissue.

The provided document is a 510(k) premarket notification for the "Achieve Programmable Automatic Biopsy Systems." This submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical effectiveness with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria in terms of a clinical outcome (like diagnostic accuracy) is largely not applicable (N/A) in the context of this specific regulatory submission. The studies detailed primarily focus on engineering and performance specifications to establish equivalence, not clinical efficacy or diagnostic accuracy compared to a ground truth established by experts.

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are performance requirements for the device's function and safety, not clinical diagnostic accuracy. The reported performance is that the device "meets or exceeds all performance requirements."

2. Sample size used for the test set and the data provenance

Since this is a submission for a biopsy device demonstrating substantial equivalence through non-clinical performance testing (not clinical diagnostic accuracy), the concept of a "test set" and "data provenance" as typically applied to AI/diagnostic algorithms with patient data is N/A.

The non-clinical tests involved:

• Material properties testing: Evaluation of materials against industry standards.
• Sterilization validation: Testing of sterilization processes.
• Performance tests: Such as biopsy sample testing, weld strength, firing speed, and ultrasound visibility.
• Sample sizes for these engineering tests are not specified in this summary.
• Data provenance: Not directly applicable in the sense of patient data origin. These are laboratory-based engineering and performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. The summary does not describe any studies involving experts establishing ground truth for diagnostic purposes. The "ground truth" for the non-clinical tests would be the established engineering standards, physical properties, or comparison to the performance of predicate devices.

4. Adjudication method for the test set

N/A. No adjudication method is described as there are no expert evaluations for clinical decision-making or diagnostic agreement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a biopsy instrument, not an AI diagnostic algorithm or imaging system. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is a medical device (biopsy system), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance studies would be:

• Engineering standards and specifications: For biocompatibility, residuals, material properties, sterilization efficacy, and packaging integrity.
• Performance metrics of predicate devices: For comparative tests like biopsy sample quality, weld strength, firing speed, and ultrasound visibility, where the proposed device's performance was compared to that of the legally marketed predicate devices to establish equivalency.

8. The sample size for the training set

N/A. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the ground truth for the training set was established

N/A. Not applicable, as there is no training set for a physical biopsy device.

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